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510(k) K131542

NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC by Novabay Pharmaceuticals, Inc. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2013
Date Received
May 29, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Novabay Pharmaceuticals, Inc.

  • K143351 — iCase Contact Lens Case (April 29, 2015)
  • K113820 — NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER (August 8, 2012)
  • K081009 — NEUTROPHASE (May 20, 2008)
  • K071056 — NEUTROPHASE WOUND CLEANSER (September 28, 2007)

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